- Launched his first international clinical trial in a cardiology clinic basement in 1989.
- Founded Evidence Clinical & Pharmaceutical Research; built it into a leading contract research organization in Eastern Europe before it was acquired by Worldwide Clinical Trials.
- Clients have included Pfizer, GlaxoSmithKline (GSK), Bristol-Myers Squibb, Boehringer Ingelheim.
- Has conducted hundreds of major clinical trials and authored more than 40 published scientific papers.
- All 6 Best Practices
- Pre-Call Discovery Process
- One-on-One Call with Expert
- Session Summary Report
- Post-Session Engagement
The clinical trials process used to test new drugs for the sick is broken and needs to be retooled.
Trials are the pivotal stage in the development of life-improving drugs before they go on the market. But they have grown too costly and lengthy, and are freighted with inefficiencies.
The industry that’s evolved to conduct and manage clinical trials has lost touch with its customers – the makers of new drugs – and to a degree with their acquiescence. The increasingly-challenged model of a cartel of service providers delivering trials in a formulaic, one-size-fits-all fashion is proving ultimately detrimental to the interests of consumers as well.
There’s a need for fresh approaches to designing, conducting and managing trials. And there’s a lot of room for improvement:
- Sponsors, in concert with their service providers, can do a better job of designing study protocols.
- Contract research organizations (CROs) can be more responsive to sponsors, opening the lines of communication that can help ensure a more seamless and possibly less costly process of qualifying drugs.
- Sponsors can be more selective in who and how many they hire to conduct their trials by being willing to move away from the “preferred provider” model that stymies innovation.
- Investigators and sites for investigation can be selected more on the basis of their suitability for a particular trial and less on their ability to be a cog in a marketing machine.
- Using the power that resides in instant communication and social media, sponsors and their partners can more actively involve trial subjects in the process.
- Trials can be run more efficiently by adopting monitoring techniques that do a better job of assessing risks and potential problem areas.
Today, clinical trials are plagued by a lack of communication, mutual trust and transparency among the various stakeholders. Investigators, service providers and sponsors pursue interests that can be at odds
Some sponsors have begun to question the old ways of approaching clinical trials. Those who scrutinize their service providers better and take more ownership of the process are advancing their ultimate goal of getting reliable answers as quickly as possible to a prospective drug's viability.